Betadine 40 mg/ml cutaneous solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Betadine soap solution 40 mg/ml cutaneous solution

Povidone iodine

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve.

Contents of the leaflet

1. What Betadine soap solution is and what it is used for.
2. What you need to know before using Betadine soap solution.
3. How to use Betadine soap solution.
4. Possible adverse effects.
5. How to store Betadine soap solution.
6. Contents of the pack and other information.

1. What Betadine soap is and what it is used for

Povidone iodine, the active substance in this medicine, is an antiseptic (which destroys germs that cause infections) containing iodine.

Betadine is indicated as an antiseptic soap used for antiseptic washing of the skin and hands in cases of minor wounds, superficial cuts, or abrasions.

2. What you need to know before using Betadine Soap

Do not use Betadine Soap

• If you are allergic to povidone-iodine or to any of the other components of this medicine (listed in section 6).
• If you have hyperthyroidism or other acute thyroid diseases.
• Before, during, and after administration of radioactive iodine.
• With products containing mercury due to the formation of a substance that may damage the skin.
• In children under one year of age.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Betadine Soap.

For external use only. Do not ingest. Avoid contact with eyes, ears, and other mucous membranes. Consult your doctor if symptoms persist or worsen.

If used for preoperative preparation, avoid accumulation under the patient. Accumulation may cause irritation and, rarely, severe skin reactions. Chemical burns of the skin may occur due to accumulation. In such cases, discontinue use. Do not heat before application.

Patients with goiter, thyroid nodules, or other non-acute thyroid diseases are at risk of developing hyperthyroidism when exposed to high iodine levels. In these patients, Betadine Soap should not be used for prolonged periods or over large skin areas unless strictly indicated. Even after treatment ends, early signs of possible hyperthyroidism should be monitored, and thyroid function should be checked if necessary.

Do not use before or after radioactive iodine scintigraphy or radioactive iodine treatment for thyroid carcinoma.

Thyroid function tests should be performed if prolonged use is necessary.

Children

Newborns and young children are at higher risk of developing hypothyroidism. When used in children, thyroid function must be monitored.

The use of Betadine medicated soap is not recommended in children under one year of age.

Use of Betadine medicated soap with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not use together with mercury-containing compounds, silver, hydrogen peroxide, or taurolidine (antiseptics).

Prolonged use should be avoided in patients receiving concomitant lithium therapy (used in psychiatry).

When used simultaneously or after antiseptics containing octenidine, transient dark discoloration of the affected areas may occur.

This medicine contains 52.5 mg of benzoic acid per 100 ml. Benzoic acid may cause local irritation.

Interaction with diagnostic tests: the use of povidone-iodine may lead to errors in toluidine or guaiacol tests for detecting hemoglobin or glucose in feces or urine. It may also interfere with thyroid function tests and treatments with radioactive iodine.

Inform your doctor if you need to undergo any diagnostic test.

Inform your doctor if:

• Symptoms do not improve or worsen
• You have received treatment with radioactive iodine within the last 4 weeks
• You have an allergy or skin irritation such as redness, small blisters, itching, or rash, which may appear immediately.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Use only if strictly indicated, and limit use to the absolute minimum. Avoid prolonged use.

Its use could cause transient hypothyroidism in fetuses and newborns. Thyroid monitoring in children may be necessary.

Consult your doctor regarding use in children between 1 and 2 years of age.

Driving and use of machines

Betadine does not affect the ability to drive or operate machinery.

3. How to use Betadine soap

Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

For cutaneous use. Use 2 to 3 times a day (or more frequently, as needed), applying a small amount of the product and rubbing for 2–5 minutes until foam forms. Rinse thoroughly with abundant water or with sterile gauze soaked in water.

If you use more Betadine soap than you should

If an excessive amount of product is applied and skin irritation occurs, wash the affected area thoroughly with abundant water, discontinue treatment, and if irritation persists, consult a doctor.

Symptoms may include abdominal pain, anuria (suppression or reduction of urine), circulatory, respiratory, and metabolic disorders. Excess iodine may cause goiter, hypothyroidism, and hyperthyroidism.

In case of accidental ingestion, go immediately to a medical center or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the product and the amount ingested.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

In rare cases where skin irritation or allergy occurs, discontinue treatment and wash the affected area with water.

Rare adverse effects (may affect between 1 and 10 out of 10,000 people) are hypersensitivity and contact dermatitis, which manifests as red skin, small blisters, and itching.

Very rarely (may affect fewer than 1 in 10,000 people), anaphylactic reactions (severe allergic reaction), hyperthyroidism with tachycardia and agitation, and angioedema (swelling caused by allergy) have been observed.

Other adverse effects of unknown frequency include hypothyroidism, electrolyte imbalance, metabolic acidosis, acute renal failure, abnormal blood osmolarity, exfoliative dermatitis, dry skin, skin discoloration, and chemical burn on the skin.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Betadine Soap Solution

Keep this medicine out of the sight and reach of children.

Store below 30°C.

Do not use this medicine after the expiry date stated on the packaging after CAD or EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Betadine Soap Solution

The active substance is povidone-iodine. Each ml of solution contains 40 mg of povidone-iodine.

The other components (excipients) are: solution of ethoxylated ammonium lauryl sulphate (containing benzoic acid), polyethylene glycol 400, sodium hydroxide, potassium iodate and purified water.

Appearance of the product and contents of the container

Brown-coloured solution.

Presented in containers of 1 high-density polyethylene bottle with black cap and reducer, containing 125 ml or 500 ml of solution.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

The Netherlands

Manufacturer

MEDA Manufacturing, Bordeaux

Av. Pdt. J. F. Kennedy. BP 100

Mérignac – Cedex

F-33700

France

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 Barcelona

Spain

Date of the most recent revision of this leaflet: July 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) https://www.aemps.gob.es/